510(k) K223902 · IYO System, Imaging, Pulsed Echo, Ultrasonic
FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)
| Applicant | Echosens, Paris, FR |
| Decision | Substantially Equivalent, Mar 2, 2023 |
| Received | Dec 28, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223902
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.